Deadly Medicines and Organised Crime: a review

This is a web version of a review of Peter Gotzsche’s book. It appeared in the April 2014 Healthwatch Newsletter. Read the whole newsletter. It has lots of good stuff. Their newsletters are here. Healthwatch has been exposing quackery since 1989. Their very first newsletter is still relevant.

Most new drugs and vaccines are developed by the pharmaceutical industry. The industry has produced huge benefits for mankind. But since the Thatcherite era it has come to be dominated by marketing people who appear to lack any conscience. That’s what gave rise to the Alltrials movement. It was founded in January 2013 with the aim of ensuring that all past and present clinical trials are registered before they start and that and their results are published The industry has been dragged, kicking and screaming, towards a new era of transparency, with two of the worst offenders, GSK and Roche, now promising to release all data. Let’s hope this is the beginning of real open science.

This version is not quite identical with the published version in which several changes were enforced by Healthwatch’s legal adviser. They weren’t very big changes, but here is the original.

Deadly Medicines and Organised Crime

As someone who has spent a lifetime teaching pharmacology, this book is a bitter pill to swallow. It makes Goldacre’s Bad Pharma seem quite mild.

In fairness, the bits of pharmacology that I’ve taught concern mostly drugs that do work quite well. Things like neuromuscular blocking agents, local anaesthetics, general anaesthetics, anticoagulants, cardiac glycosides and thyroid drugs all do pretty much what is says on the label.

Peter Gøtzsche is nothing if not evidence man. He directs the Nordic Cochrane group, and he talks straight. His book is about drugs that don’t work as advertised. There is no doubt whatsoever that the pharmaceutical industry has behaved very badly indeed in the last couple of decades. You don’t have to take my word for it, nor Peter Gotzche’s, nor Ben Goldacre’s. They have told us about it themselves. Not voluntarily of course, but in internal emails that have been revealed during court proceedings, and from whistleblowers.

Peter Rost was vice president marketing for the huge pharmaceutical company, Pfizer, until he was fired after the company failed to listen to his complaints about illegal marketing of human growth hormone as an anti-ageing drug. After this he said:

“It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry … “

The pharmaceutical industry is the biggest defrauder of the US federal government under the False Claims Act. Roche led a cartel that, according to the US Justice Department’s antitrust division, was the most pervasive and harmful criminal antitrust conspiracy ever uncovered. Multibillion dollar fines have been levied on all of the big companies (almost all in the USA, other countries have been supine), though the company’s profits are so huge they are regarded as marketing expenses.

It’s estimated that adverse effects of drugs kill more people than anything but cancer and heart disease, roughly half as many as cigarettes. This horrifying statistic is announced at the beginning of the book, though you have to wait until Chapter 21 to find the data. I’d have liked to see a more critical discussion of the problems of causality in deciding why someone died, which are just as big as those in deciding why somebody recovered. Nevertheless, nobody seems to deny that the numbers who are killed by their treatments are alarmingly high.

Gøtzsche’s book deals with a wide range of drugs that don’t do what it says on the label, but which have made fortunes because of corruption of the scientific process. These include non-steroidal anti-inflammatory drugs (NSAIDs), an area described as “a horror story filled with extravagant claims, bending of the rules, regulatory inaction, . . .”. Other areas where there has been major misbehaviour include diabetes (Avandia), and the great Tamiflu scandal. and the great Tamiflu scandal. It took five years of pressure before Roche released the hidden data about Tamiflu trials. It barely works. Goldacre commented “government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic”

But the worst single area is psychiatry.

Two of the chapters in the book deal with psychiatry. Nobody has the slightest idea how the brain works (don’t believe the neuroscience hype) or what causes depression or psychosis. Treatments are no more than guesses and none of them seems to work very well.

The problems with the SSRI antidepressant, paroxetine (Seroxat in UK, Paxil in USA) were brought to public attention, not by a regulator, but by a BBC Panorama television programme. The programme revealed that a PR company, which worked for GSK, had written

“Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise.”

This referred to the now-notorious study 329. It was intended to show that paroxetine should be recommended for adolescent depression. The paper that eventually appeared in 2001 grossly misrepresented the results. The conclusions stated “Paroxetine is generally well tolerated and effective for major depression in adolescents”, despite the fact that GSK already knew this wasn’t true. The first author of this paper was Martin Keller, chair of psychiatry at Brown University, RI, with 21 others.

“Keller is some character. He double- billed his travel expenses, which were reimbursed both by his university and the drug sponsor. Further, the Massachusetts Department of Mental Health had paid Brown’s psychiatry department, which Keller chaired, hundreds of thousands of dollars to fund research that wasn’t being conducted. Keller himself received hundreds of thousands of dollars from drug companies every year that he didn’t disclose.”

His department received $50 million in research funding. Brown University has never admitted that there was a problem. It still boasts about this infamous paper

Where were the regulatory agencies during all this? The MHRA did ban use of paroxetine in adolescents in 2003, but their full investigation didn’t report until 2008. It came to much the same conclusions as the TV programme six years earlier about the deceit. But despite that, no prosecution was brought. GSK got away with a deferential rap on the knuckles.

Fiona Godlee (editor of the BMJ, which had turned down the paper) commented

“We shouldn’t have to rely on investigative journalists to ask the difficult questions”

Now we can add bloggers to that list of people who ask difficult questions. The scam operated by the University of Wales, in ‘validating’ external degrees was revealed by my blog and by BBC TV Wales. The Quality Assurance Agency came in only at the last moment. Regulators regularly fail to regulate.

Despite all this, the current MHRA learning module on SSRIs contains little hint that SSRIs simply don’t work for mild or moderate depression. Neither does the current NICE guidance. Some psychiatrists still think they do work, despite there being so many negative trials.

The psychiatrists’ narrative goes like this. You don’t expect to see improvements for many weeks (despite the fact that serotonin uptake is stopped immediately). You may get worse before you get better. And if the first sort of pill doesn’t work, try another one. That’s pretty much identical with what a homeopath will tell you. The odds are that its meaning is, wait a while and you’ll get better eventually, regardless of treatment.

It’s common to be told that they must work because when you stop taking them, you get worse. But, perhaps more likely, when you stop taking them you get withdrawal symptoms, because the treatment itself caused a chemical imbalance. Gøtzsche makes a strong case that most psychiatric drugs do more harm than good, if taken for any length of time. Marcia Angell makes a similar case in The Illusions of Psychiatry.

“Merck stated only 6 months before it withdrew Vioxx that ‘MSD is fully committed to the highest standards of scientific integrity, ethics, and protection of patient’s wellbeing in our research. We have a tradition of partnership with leaders in the academic research community. Great. Let’s have some more of such ethical partnerships. They often kill our patients while everyone else prospers.

Perhaps Hells Angels should consider something similar in their PR: We are fully committed to the highest standards of integrity, ethics and protection of citizens’ well- being when we push narcotic drugs. We have a tradition of partnership with leaders in the police force”.

But the evidence is there. The book has over 900 references. Much of the wrongdoing has been laid bare by legal actions. I grieve for the state of my subject.

The wrongdoing by pharma is a disgrace.

The corruption of universities and academics is even worse, because they are meant to be our defence against commercial corruption.

All one can do is to take consolation from the fact that academics, like Gøtzsche and Goldacre, and a host of bloggers, are the people who are revealing what’s wrong. As a writer for the business magazine, Fortune, said

“For better or worse, the drug industry is going to have to get used to Dr. Peter Rost – and others like him.”

At a recent meeting I said that it was tragic that medicine, the caring profession, was also the most corrupt (though I’m happy to admit that other jobs might be as bad if offered as much money).

At present there is little transparency. There is no way that I can tell whether my doctor is taking money from pharma, data are still hidden from public scrutiny by regulatory agencies (which are stuffed with people who take pharma money) as well as by companies. Governments regard business as more important than patients. In the UK, the Government continued promotion of the fake bomb detector for many years after they’d been told it was fake. Their attitude to fake medicines is not much different. Business is business, right?

One side effect of the horrific corruption is that it’s used as a stick by the alternative medicine industry. That’s silly of them, because their business is more or less 100% mendacious marketing of ineffective treatments. At least half of pharma products really do work.

Fines are useless. Nothing will change until a few CEOs, a few professors and a few vice-chancellors spend time in jail for corruption.

GSK recalls vaccine made at troubled plant in Canada

GlaxoSmithKline ($GSK) is recalling 1.7 million doses of its quadrivalent flu vaccine that was manufactured at a plant that ran into a series of manufacturing issues last year including an FDA warning letter. The company says there are questions about whether the vaccine is retaining its potency.

“As part of stability testing, GSK observed loss of potency below the minimum specification prior to product expiry for the B strains included in the vaccine,” the drugmaker said in a letter to distributors and healthcare providers issued last week. “The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern.”

In an emailed statement, GSK spokeswoman Anna Padula said the voluntary recall to U.S. customers was “for all remaining doses of FluLaval Quadrivalent Thimerosal-Free (Influenza) Vaccine, in the Pre-Filled Syringe, which were provided to the U.S. market for the 2014/15 flu season.” According to the Associated Press, it was unknown how many of the 1.7 million units were still on the market since 99% of it was distributed in 2014, before the potency began to wane.

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In a follow-up telephone interview, Padula said the problem that led to the recall was not tied to the issues raised last year by the FDA in the warning letter to the plant in Quebec City where the vaccine is manufactured. She said the Canadian plant does all of the manufacturing of the vaccine except the fill and finish work, which is done at a plant in Belgium. She said it was “premature to comment on the potential root causes,” and whether they were tied to the manufacturing or the fill/finish work, “because we are still investigating.”

The company had to actually reduce the amount of vaccine it shipped last year after a series of manufacturing problems at the Quebec City plant. The FDA issued a warning letter in June in which it raised concerns about bacterial contamination, questioning the quality of the new FluLaval vaccine and its intermediates. The agency pointed out that there have been problems with the purified water at the plant for years, including alerts because of organisms, including Ralstonia pickettii and Achromobacter xylosoxidans, both of which have been implicated in product contamination that dates back to 2011.

GSK’s efforts to fix some of the issues did not resolve them, leading GSK to resort to a manufacturing process it had used in the past. But then it had to temporarily suspend production to investigate “irregular results” in quality-control monitoring. It also reported getting an “invalid test result on one component of the trivalent vaccine,” which required retesting. The issues led it to reduce the amount of vaccine that it could ship from the plant.

This past season’s flu vaccines posted one of the worst efficacy rates in recent memory. That had been blamed on the fact that the viral strains the vaccines contained did not closely match the ones that ended up circulating.

London-based GlaxoSmithKline is the product of the 2000 merger of two drug giants: Glaxo—which had its origins in the infant formula business and then jumped to the top ranks of the pharmaceutical industry on the basis of the extraordinarily popular ulcer drug Zantac—and SmithKline Beecham, which was itself the product of a merger of a U.S. and a British drugmaker and had a broader portfolio of drugs, including the competing ulcer medication Tagamet and the ill-fated diabetes drug Avandia.

In recent years, GlaxoSmithKline has become known as the company that pays massive amounts to resolve wide-ranging charges brought by U.S. regulators and prosecutors. These included a $750 million payment relating to the sale of adulterated products from a facility in Puerto Rico and a record $3 billion in connection with charges relating to illegal marketing, suppression of adverse safety research results and overcharging government customers. The company also set a record for the largest tax avoidance settlement with the U.S. Internal Revenue Service.

Product Safety

In 1984 the U.S. Food and Drug Administration (FDA) brought charges under the little used criminal provisions of federal drug laws against what was then known as SmithKline Beckman, alleging that the company failed to warn regulators and the public about potentially lethal side effects associated with its blood pressure medication Selacryn. Several company officials were also charged with misdemeanor offenses. The company later pleaded guilty, and three officials pleaded no contest. The judge in the case ordered SmithKline to give $100,000 to an organization working to prevent child abuse; the officials were each sentenced to five years of probation and 200 hours of community service.

In 2003 regulators in Britain warned that use of GlaxoSmithKline’s antidepressant Seroxat (the UK name for Paxil) by children could increase suicidal thoughts and should not be prescribed for them. The FDA followed with a similar recommendation and subsequently ordered that a “black box warning” be added to the drug’s packaging. In 2004 New York Attorney General Eliot Spitzer filed suit against the company, accusing it of suppressing research that reached negative conclusions on the efficacy of Paxil. The case was later settled, with GlaxoSmithKlineagreeing to take the unusual step of disclosing the results of its clinical trials for Paxil and other drugs.

The company later came to regret that agreement. In a review of the data posted by the company on clinical trials involving its diabetes drug Avandia, researchers at the Cleveland Clinic concluded that the medication posed a heightened risk of heart attacks. The New York Timesdiscovered that the FDA had been warned of such risks years earlier. Over the following months and years, more and more information came to light questioning the safety of Avandia, prompting actions such as a move by the U.S. Department of Veterans Affairs to sharply curtain use of the drug.

In 2010 an FDA reviewer issued a scathing critique of the clinical trial GlaxoSmithKline had used to argue for the safety of Avandia, concluding that the company had excluded information about numerous instances in which users experienced severe medical complications. It was then reported that the company had spent more than a decade covering up research results showing that Avandia performed no better a competing medication.

Also in 2010, an FDA advisory panel recommended that Avandia either be withdrawn from the market or severely restricted in its use. A European panel later did the same. In July 2010 GlaxoSmithKline announced it would take a $2.4 billion charge against earnings to cover legal liabilities related to Avandia. (Six months later, the company took another charge of $3.4 billion.)

In October 2010 GlaxoSmithKline agreed to pay a total of $750 million—$150 million in connection with federal False Claims Act charges and $600 million for state claims—to settle civil and criminal complaints that it knowingly sold adulterated drugs produced at a subsidiary’s troubled plant in Puerto Rico. Among the products were Avandia, Paxil and the baby ointment Bactroban.

In 2011 the U.S. law firm Hagens Berman filed suit against GlaxoSmithKline, charging that its predecessor company Smith, Kline and French conducted a trial of Thalidomide in the 1950s and buried evidence of the dangers of the German drug, which ended up causing thousands of horrific cases of deformities in children.

In July 2012 the U.S. Justice Department announced that GlaxoSmithKline would pay $3 billion to settle various criminal and civil charges, among which were allegations that the company withheld crucial safety data on Avandia from the FDA. Those charges accounted for $899 million of the total: $242 million in criminal fines and $657 million in civil payments ($508 million to the federal government and $149 million to states).

The company’s commitment to Avandia paid off in mid-2013, when an FDA advisory panel called for easing restrictions on the drug.

Pricing and False Claim Controversies

In 1996 SmithKline Beecham was one of 15 drug companies that together agreed to pay more than $408 million to settle a class action lawsuit charging them with conspiring to fix prices they charged to thousands of independent pharmacies. In addition to contributing $30 million to the financial settlement, SmithKline agreed to supply the plaintiffs with a quantity of the generic version of its Tagamet ulcer medication worth $20 million.

In 1997, following an investigation dubbed Operation LabScam by federal investigators, SmithKline Beecham Clinical Laboratories agreed to pay $325 million to settle charges that it had overcharged Medicare by billing for millions of laboratory tests that were not medically necessary, were not ordered by a physician or were not performed. At the time, the amount set a record for a healthcare-related civil settlement.

In 2000, after Maine passed a law allowing price controls on prescription drugs, SmithKline Beecham responded by warning it would no longer ship its products to wholesalers in the state.

In 2001 GlaxoSmithKline and other major pharmaceutical companies dropped a lawsuit they had filed to block a plan by the South African government to import relatively inexpensive drugs to deal with the country’s AIDS epidemic.

In 2003 GlaxoSmithKline agreed to pay $87.6 million to the federal government to resolve charges that it sold its antidepressant Paxil and its allergy spray Flonase to the Medicaid program at inflated prices.

In 2004 GlaxoSmithKline announced that it would pay $175 million to settle a lawsuit brought by drug wholesalers contending that it violated antitrust laws by blocking cheaper generic forms of its Relafen arthritis medication.

In 2005 GlaxoSmithKline agreed to pay $150 million to resolve federal government allegations that the company violated the False Claims Act through fraudulent pricing and marketing of two anti-nausea drugs sold to the Medicare and Medicaid programs for use primarily by cancer patients. The following year, the company agreed to pay $70 million to settle related suits brought by state governments.

In 2006 GlaxoSmithKline agreed to pay $14 million to settle allegations by state governments that it inflated prices for Paxil by engaging in patent fraud, antitrust violations and frivolous litigation to maintain a monopoly and block generic versions of the medication from entering the market.

The $3 billion settlement GlaxoSmithKline reached with the federal government in 2012 included a payment of $300 million to resolve charges that the company reported false drug prices, allowing it to underpay rebates it owed under the Medicaid Drug Rebate Program and to overcharge certain Public Health Entities. Of the $300 million, $161 million was to go to the federal government, $119 million to the states and $20 million to Public Health Service entities.

In April 2013 the UK Office of Fair Trading charged GlaxoSmithKline with violating competition laws by paying other companies to delay the introduction of generic versions of its antidepressant Seroxat (sold in the U.S. as Paxil).

Marketing and Advertising Controversies

In 1993 the FDA ordered Glaxo to stop making what the agency called false and misleading statements about the effectiveness of the company’s best-selling anti-ulcer drug Zantac.

In 2004 the FDA sent a warning letter to GlaxoSmithKline charging that a TV advertisement for Paxil was false and misleading. That same year, the FDA sent a warning letter to the company alleging that promotional materials for three hepatitis drugs contained false or misleading statements.

In 2008 the FDA sent a warning letter to GlaxoSmithKline alleging that materials the company was sending health practitioners to promote its breast cancer drug Tykerb were misleading because they omitted serious risks.

Among the charges covered by the $3 billion settlement that the U.S. Justice Department reached with GlaxoSmithKline in 2012 were criminal and civil allegations relating to the unlawful marketing of Paxil, the antidepressant Wellbutrin and other drugs for unapproved purposes. That marketing allegedly included kickbacks paid to doctors and other health professionals to get them to prescribe and promote the drugs for those unauthorized uses. Payments also went to people such as radio personality Drew Pinsky, who was paid $275,000 by the company to promote Wellbutrin on his program.

The settlement included $757 million in criminal fines and forfeitures as well as $1.04 billion in connection with the civil charges—$832 million to the federal government and $210 million to state governments. GlaxoSmithKline was also compelled to sign a 122-page Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services that lists numerous measures the company had to adopt to make it more likely to comply with federal laws and regulations.

In July 2013 the Chinese government accused Glaxo of using bribes, kickbacks and other fraudulent methods to increase its drug sales in China. The company was said to have laundered the payments through travel agencies. Glaxo was later fined $500 million in the matter.

Human Rights

Before Glaxo’s infant formula business was sold off in the late 1980s, that operation was the subject of controversy. Like many other formula producers, Glaxo had been accused of violating World Health Organization standards for the marketing of formula in poor countries. Religious and public health advocates had pressured the World Health Organization to adopt guidelines to discourage aggressive marketing of the formula in situations where mothers were often compelled to mix the powder with impure water or dilute the formula to the extent that it became much less nutritional than breast milk.

Environmental

In 2008 the U.S. Justice Department announced that GlaxoSmithKline and two other companies would pay a $500,000 civil penalty in connection with the release of trichloroethylene (TCE) into the public drinking water system of Scottsdale, Arizona.

Executive Compensation

In 2003 shareholders in GlaxoSmithKline were the first to make use of a new investor-protection law enacted in Britain that year when they voted to reject a lucrative pay packages proposed for chief executive Jean-Pierre Garnier and other top executives.

Taxes

In 2006 GlaxoSmithKline said it would pay $3.1 billion to the U.S. Internal Revenue Service to resolve a 17-year dispute over the tax treatment of transactions between the company’s U.S. operation and the parent company. The settlement, the largest in IRS history, focused on the issue of transfer pricing—a method by which transnational corporations artificially reduce their tax liabilities.

Employment Issues

In 1999 SmithKline Beecham agreed to pay $19,000 to settle allegations that the company retaliated against an employee who reported to management apparent violations of the anti-discrimination provisions of the Immigration and Nationality Act.

Stewart Dolin killed himself in 2010 by jumping in front of a train in Chicago. His wife, Wendy, filed suit alleging that Paxil had caused her husband to develop akathisia, a condition that causes psychological agitation.

GSK argued that Dolin was taking the generic version of Paxil marketed and manufactured by Mylan, ergo they were not responsible for the drug inducing suicide. However, a U.S. District Judge told Mylan that they would not have to face any trial but said Glaxo was responsible for the generic drug’s design and warning label and would have to face negligence claims.

Bitter, Glaxo then went on to subpoena Wendy Dolin’s cellphone and text message records, her home phone and her late husband’s company phone. So far, GSK have sent more than 30 subpoenas and over 70 records requests, and shown the Dolin children their father’s confidential therapy notes despite Wendy Dolin’s objections. According to Wendy Dolin’s motion GSK have also questioned her about romantic life since her husband’s death. Quite why they have questioned her about her life after her husband’s death is beyond me. It does, however, show how low GSK, and their multi-million dollar law firm that represent them, will stoop to defend yet another Paxil suicide.

If all this wasn’t enough, GSK have now, it appears, twisted the knife further into the stomach of Wendy Dolin by attempting to push the trial’s start date into 2016.

Law 360 (Subscription) are reporting that GSK’s attorneys, King & Spalding, have told an Illinois federal judge that they don’t have time to prepare, this, despite the case being filed over four years ago. King & Spalding are claiming that they are working on two other cases and don’t have time to prepare themselves for the Dolin case.

I can’t quite get to grips with GSK’s apparent disdain for Wendy Dolin nor the lack of respect they are clearly not showing regarding the memory of Stewart Dolin.

I’ve gone on record many times stating that I do not like GSK or their attorneys, King & Spalding. I do not like the way they operate nor do I like what they each try to suppress regarding items of discovery (You really do need to read the Joanne Thomas articles to see exactly what they try to suppress)

As for GSK trying to blame Mylan, well, that doesn’t really surprise me. Mylan sold Paxil under a generic name and Glaxo conveniently forgot to tell them about warning potential patients that Paxil may cause suicide. It’s akin to a car salesperson selling you a car and failing to mention that the brakes don’t work!

A pretty decent analogy given that earlier this year it was revealed that General Motors Co.’s emails with King & Spalding LLP and other outside counsel show the automaker engaged in a “massive cover-up” to hide its deadly ignition switch defect. (Source)

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” I had the life squished out of me by psychiatry… I didn’t see myself as a human being at all” – one of the many voices of the psychiatric survivors in this video. Well worth watching… are you going to watch this Ben Goldacre and Simon Wessely or are you going to continue to ignore all these people, similar psychiatric survivors, and their experiences?…

The below video is a couple of years old and I somehow missed it. It’s really wonderful and well worth watching. I hope to be able to attend one of these congresses soon. I am starting to entertain the idea of traveling again, though I’m not sure yet when that might happen.

“Voices Matter” is a documentary about the global Hearing Voices Movement, filmed at the 2012 World Hearing Voices Congress in Cardiff, Wales. For more info visit the Open Paradigm Project.

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Below I’m cutting and pasting a post from the archives with some commentary and a collection of links on voice hearing.

Hearing voices: living and thriving as voice hearers

Some commentary and a collection of posts that look at voice hearing and how to cope with them and grow and heal with them too.

I found the below excerpted article about a therapist who uses what she…

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Psychiatry Under the Influence: Institutional Corruption, Social Injury, and Prescriptions for Reform

Psychiatry Under the Influence investigates how the influence of pharmaceutical money and guild interests has corrupted the behavior of the American Psychiatric Association and academic psychiatry during the past 35 years. The book documents how the psychiatric establishment regularly misled the American public about what was known about the biology of mental disorders, the validity of psychiatric diagnoses, and the safety and efficacy of its drugs. It also looks at how these two corrupting influences encouraged the expansion of diagnostic boundaries and the creation of biased clinical practice guidelines. This corruption has led to significant social injury, and in particular, a societal lack of informed consent regarding the use of psychiatric drugs, and the pathologizing of normal behaviors in children and adults. The authors argues that reforming psychiatry will require the neutralization of these two corrupting influences—pharmaceutical money and…

The belief that the most popular antidepressant drugs raise serotonin levels in the brain is nothing more than a myth, a leading professor of psychiatry has claimed.

David Healy, head of psychiatry at the Hergest psychiatric unit in Bangor, North Wales, said the misconception that low levels of serotonin were responsible for depression had become established fact.

He suggested that the success of so-called SSRI drugs – which include Prozac and Seroxat – was based on the ‘marketing of a myth’.

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The idea that the most popular antidepressant drugs raise serotonin levels in the brain is nothing more than a myth, psychiatrist Professor David Healy argues. Pictured is Prozac, one commonly prescribed SSRI

The emergence of these serotonin reuptake inhibiting (SSRI) drugs in the late 1980s came after concerns about tranquilliser use to treat depression.

Even though they were weaker than old-style tricyclic antidepressants, they took off because of the idea that SSRIs restored serotonin levels to normal, ‘a notion that later transmuted into the idea that they remedied a chemical imbalance’.

In an editorial in the BMJ, Professor Healy said that in the 1990s, no one knew if SSRIs raised or lowered serotonin levels but there was no evidence that treatment corrected anything.

He said: ‘For doctors it provided an easy short hand for communication with patients.

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‘For patients, the idea of correcting an abnormality has a moral force that can be expected to overcome the scruples some might have had about taking a tranquilliser, especially when packaged in the appealing form that distress is not a weakness.’

However, other psychiatrists have refuted the professor’s claims, saying the profession has moved on from a simplistic description of the pills correcting a chemical imbalance.

They warned the controversy might harm depressed patients if they were deterred from taking the drugs, which had been proved to work in trials and the ‘real world’.

COULD DEPRESSION BE AN INFECTIOUS DISEASE?

Depression should be re-defined as an infectious disease rather than an emotional disorder, argues one scientist.

The condition could result from a parasitic, bacterial or viral infection and future research into the condition should search for these micro-organisms, argues Dr. Turhan Canli, of Stony Brook University, U.S.

If his theory is true, he hopes a vaccination to protect against depression could be developed in future.

Writing in the journal Biology of Mood and Anxiety Disorders, Dr Canli said: ‘It is time for an entirely different approach.

‘Instead of conceptualising major depression as an emotional disorder, I suggest to re-conceptualise it as some form of an infectious disease.

‘I propose that future research should conduct a concerted search for parasites, bacteria, or viruses that may play a causal role in the etiology of major depression.’

Professor Sir Simon Wessely, President of the Royal College of Psychiatrists, said: ‘That antidepressants are helpful in depression, together with psychological treatments, is established. How they do this is not.

‘Most researchers have long since moved on from the old serotonin model.

‘Most important of all, SSRIs are safer if taken in overdose than the older tricyclics.

‘People should not change their current medication on the basis of this editorial alone.’

NHS Choices, the website which advises patients, says: ‘It would be too simplistic to say that depression and related mental health conditions are caused by low serotonin levels, but a rise in serotonin levels can improve symptoms.’

Professor Healy’s editorial says it is important to raise questions about the drugs.

He said: ‘In other areas of life the products we use, from computers to microwaves, improve year on year, but this is not the case for medicines, where this year’s treatments may achieve blockbuster sales despite being less effective and less safe than yesterday’s models.

‘The emerging sciences of the brain offer enormous scope to deploy any amount of neurobabble.

‘We need to understand the language we use. Until then, so long, and thanks for all the serotonin’, he concludes.

Professor David Taylor, Director of Pharmacy and Pathology and Head of Pharmaceutical Sciences Clinical Academic Group, King’s Health Partners, South London and Maudsley NHS Foundation Trust, said: ‘Professor Healy makes a forceful but poorly supported argument against something which doesn’t and has never really existed: the idea that SSRIs ‘correct’ an ‘imbalance’ of serotonin in the brain.

‘Researchers and psychiatrists alike know that SSRIs are effective in a number of disorders but no one is sure exactly how they work. Their readily demonstrable effect is on serotonin but they have many indirect secondary effects in the brain.

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Other psychiatrists warned the controversy might harm depressed patients if they were deterred from taking the drugs, which had been proved to work in trials and the ‘real world’

‘Prof Healy fails to mention that SSRIs supplanted earlier tricyclics largely because of their relative safety in overdose, not because of any conspiracy concerning a theory of serotonin’s involvement in depression.’

Dr Paul Keedwell, Consultant Psychiatrist and Specialist in Mood Disorders, said: ‘In the real world of the clinic, SSRIs are undeniably effective in treating individuals with major depression.

‘They have become the first line treatment of choice because they have fewer troublesome side-effects than their predecessors, and are safer in overdose.

Law, Social Science, and Policy

Prosecuting GSK: How to Deal with Being Second in Line

As followers of the anticorruption blogosphere know, China recently fined British pharmaceutical giant GlaxoSmithKline (“GSK”) $490 million for bribing Chinese doctors and hospital administrators. There is no need rehash here what many others have already said: this case is likely a watershed moment marking China’s emergence as a force in the global fight against corruption.

But there is another aspect of the story that has gone unnoticed: With rare exceptions, the U.S. Government’s corporate FCPA settlements have either preceded any foreign enforcement action (e.g., Total) or been announced as part of a coordinated global settlement (e.g., Siemens). But China’s prosecution of GSK has put U.S. regulators in a relatively unfamiliar position: that of the second mover. And in doing so, China has forced the Department of Justice to confront a difficult question: Should it care that China has already fined GSK for the same conduct that DOJ is investigating.

Because the United States does not recognize international double jeopardy, China’s action poses no legal obstacle to an FCPA prosecution. In fact, the only legal obligation imposed on U.S. authorities as a result of China’s prosecution derives not from domestic law but from the UN Convention Against Corruption (UNCAC) art. 42(5) and OECD Anti-Bribery Convention art. 4.3. But these sections only require the United States to consult with China regarding the two nations’ overlapping investigations, and even then, only “as appropriate.”

Nevertheless, it’s a safe bet that when it comes time to resolve the GSK matter, DOJ will (1) consider the impact of the prior Chinese penalty and (2) soften its settlement terms as a result. How do we know that? Well, to start, the U.S. Attorney’s Manual — in two relevant provisions (here and here) — advises federal prosecutors to consider the effect of another jurisdiction’s (realized or potential) prosecution when deciding whether it is necessary to charge a particular target. More importantly, though, whether we are speaking of the rare FCPA case where DOJ was the second mover (e.g., Statoil or Alcatel-Lucent) or the many instances where DOJ resolved an investigation as part of a global settlement (e.g., Siemens), on several occasions DOJ seems to have adjusted its settlement demands in order to accommodate penalties exacted by foreign enforcers.

But even if DOJ has done this sort of thing in the past, it’s worth considering why it makes sense to do it again here. After all, the GSK case is a world apart from the Statoil or Alcatel-Lucent resolutions, which followed foreign settlements totaling only a few million dollars. And unlike massive global settlements like Siemens, there was — perhaps unsurprisingly — no coordination here between U.S. and Chinese enforcers.

Stepping back, there are a few reasons to believe DOJ both will and should stick to its past practice and lower its settlement demands even in a case like GSK:

Doing so may encourage additional demand-side prosecutions: For years, the anticorruption world has decried the lack of demand-side enforcement. (This blog being no exception.) The good news is that a policy of accommodating foreign penalties may help address the problem, even if only marginally and only in the long term. This practice shows respect for a demand-side nation’s sovereignty and its interest in redressing harm caused to it by the defendant’s bribery. Furthermore, a regular and open practice of deference to foreign actions will encourage goodwill between demand- and supply-side authorities, possibly leading to greater coordination of future investigations. (If demand-side officials believe they’ll be afforded their due at the bargaining table, they may be more willing to cooperate with foreign authorities in the future.) Lastly, companies are more likely to cooperative with demand-side investigations when they know that any associated penalty will be taken into account in future supply-side settlement negotiations.

Such reductions may be necessary to avoid overdeterrence: While many of us would like to stamp out transnational bribery, there is a theoretical point at which enforcement penalties become so high as to pressure companies into taking inefficient precautions (or avoiding certain high-risk markets altogether). To the extent we care about cost-effective responses to corruption, the prospect of overdeterrence is worrisome. Keeping that concern in mind, one could argue that over the past few decades — an era in which U.S. enforcement was the only big game in town — FCPA penalties were inflated to account for harm done to both supply- and demand-side countries. If that’s true, then it makes sense to reduce penalties in FCPA cases that follow (e.g., GSK) or foreseeably precede (e.g., Akzo Nobel) demand-side prosecutions in order to avoid cumulative penalties disproportionate to the underlying conduct.

In some cases, DOJ won’t have a choice: At the end of the day, there are going to be some companies (e.g., Innospec) who would fold under the financial pressure of successive penalties for the same underlying bribery conduct. It’s not a stretch to say that in a post-Arthur Andersen world, that is an outcome rarely desired by prosecutors. Sure, there are closely-held corporations who will not survive FCPA prosecutions (e.g., Nexus), but more often DOJ officials will treat the policy requirement that they weigh the collateral consequences of initiating a corporate prosecution as reason not to push the boundaries of the defendant’s financial well-being. And even with a company as large as GSK, half of a billion dollars may be a penalty large enough to make DOJ officials worry about not pushing the business too far towards the financial breaking point.

At the end of the day, I wouldn’t be surprised if DOJ’s FCPA prosecutors never quite adjust to the prospect of being second-in-line. But for the health of the global effort to combat transnational bribery — and the reasons given above — it might be best for DOJ to get used to that position. I’ve got my fingers crossed, after all, that GSK is just the latest sign of a growing phenomenon: that of demand-side countries charging forward with their own enforcement actions, even before supply-side countries can do the same.

Interesting arguments. Is the Chinese subsidiary of GSK actually registered and trading on the US stock exchange, or is it the parent company; and is this or should it be relevant to the possibility of the same action being taken in multiple jurisdictions? In the case of this British company, what, if anything, would inhibit the UK from filing against this company for the same events pursuant to the UK Antibribery law? In this same line of thought, we have not only the risk of multinational companies being fined in two, but three or as many countries as may have similar antibribery laws and registered stock, which may or may not take such multiple fines into consideration depending upon their particular laws, jurisprudence and customs. Perhaps the time is coming near for a review of the reach of the FCPA.

I believe the US is asserting FCPA jurisdiction over GSK on the basis of its status as an issuer on a US exchange. I also believe that you are correct that, under the UK Bribery Act, the UK would also have jurisdiction, though the UK (unlike the US) recognizes the principle of international double jeopardy (ne bis in idem), and so wouldn’t be able to bring a prosecution after a US settlement, and is probably already barred from doing so by the Chinese settlement. (It’s possible I’m wrong, as I’m not an expert in this feature of British law, but I think that’s the case.)

Your more general observation seems to me to be correct: We’re moving into a world in which multiple sovereigns may have jurisdiction to bring corruption charges against the same entities for the same underlying conduct: If a Korean subsidiary of a British company listed on the New York Stock Exchange pays bribes in China, then four country’s laws have been simultaneously violated, and in principle any of the four, or some combination, might be able to pursue criminal enforcement actions.

I’m not sure I agree with your last sentence, though. I think it would be a mistake to narrow the reach of the FCPA, both because it remains by far the most robust and effective law against transnational bribery, and because if a foreign company avails itself of US securities markets or territory, than the US has every right to impose and enforce legal restrictions on that firm’s conduct. Rather than narrowing the scope of the law, I’d be more inclined to deal with the problem — as Jordan suggests — through formal or informal agreements between the DOJ/SEC and other countries’ law enforcement agencies about which country or countries should take the lead in which prosecutions, and how they should coordinate.

Great analysis (and comment). I’m going beyond the scope of your post here but, to pick up on something you touched upon briefly, one way for DOJ prosecutors to avoid being second-in-line is to coordinate investigations. There are obvious benefits to global coordination on actions against cross-border crime like bribery and a number of law firms have flagged the huge growth potential for such cooperation. In the GSK case, for instance, the SFO worked closely with Chinese authorities for the first time.

For a variety of reasons, collaborating with demand-side jurisdictions seems markedly different from working alongside other supply-side authorities (although, if the Chinese government is serious about its anti-corruption campaign, maybe not as different as it first appears). At any rate, I don’t see Chinese and U.S. prosecutors cozying up to each other anytime soon.

But, particularly given the likelihood that Chinese enforcement is on the rise, what do you think of the prospects for increased investigation and settlement coordination between the U.S. and China?

Absolutely, coordinated enforcement is the way to go in most of these cases. The cooperation between the US and German authorities in the Siemens case is a great example.

The problem, as I understand it, in the GSK case is precisely the lack of coordination — due in part to lack of familiarity and lack of trust — between the Chinese and US authorities. (I don’t have a public source for this, but I’ve had informal conversations with lawyers on both the US and Chinese side about this, and they all made more or less that claim.) That’s not to say that this issue is unique to China, but I think it’s likely to be especially acute in that case. But your note about the degree of cooperation between the Chinese authorities and the SFO — which is something I wasn’t aware of — is perhaps encouraging.

This is a pretty basic question–just informational–but in relation to your first point and your references to fostering good will and demonstrating respect, is there a sense among demand-side countries that they would prefer the U.S. NOT prosecute for conduct for which the demand-side country has already secured a conviction? Assuming they’ve already received the fine they’ve assessed/been able to enact the punishment they’ve decided on, do they care what the U.S. does? If so, why? From their perspective, is it a matter of being afraid that the U.S. will (as you allude to in your third point) assess a penalty that causes the company to fold and not be able to pay the demand-side country? Just a philosophical matter of it seeming that the U.S. doesn’t view their legal decision as “real” enough to prevent further prosecution (i.e., basically objecting to the U.S. choice not to recognize international double jeopardy)?

New Drug Targets Cancer Caused By Asbestos

Mesothelioma lung cancer can come to those persons who loved, and simply hugged their parent who worked around asbestos. For example, now at age 45, Heather Von St. James recalls her father working as a building demolition employee around materials containing asbestos. He would return home each day thoroughly covered by dirt and dust. She remembers how much she enjoyed hugging her father each night.

By age 36, Heather was diagnosed with mesothelioma, the deadly yet to be cured cancer connected with exposure to asbestos particles. Mesothelioma can take decades to develop and it often kills within months after symptoms appear. Heather was a new mother to a 3-month-old daughter, and she was told her only chance to live was by having a lung removed.

In 2013, more than 107,000 people died worldwide from mesothelioma. However, Heather opted for the surgery instead, and removed the disease in time to stay alive. According to Ms. St. James, “There’s a lot of people who don’t.”

Fortunately for other people with mesothelioma, or those that will discover they have the deadly disease, a new wave of drugs developed and being tested are giving new hope that mesothelioma cancer may be slowed or stopped. Drug researchers, like Verastem Inc. (VSTM), GlaxoSmithKline Plc (GSK), and Dr. Parkash Gill of the USC Norris Comprehensive Cancer Center have announced that they are testing new cancer fighting drugs.

Carolyn Buser-Doepner (VP for tumor signaling at Glaxo, the U.K.’s biggest drugmaker), there are plans to combine a new drug GSK2256098 with some other medicines to potentially make cancer treatments more effective. In one early-stage trial, it will be paired up with Glaxo’s Mekinist, which is approved for melanoma. She said, “The pre-clinical data are very encouraging. We’re very excited about it.”

Mesothelioma Information

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Last year I received an e-mail from a whistle-blower based at the GSK (Stiefel) site who claimed that there was a major contamination problem at this GSK site in Sligo in Ireland. Allegedly, there was asbestos contamination which affected a few GSK drugs that are manufactured there (and also according to these claims- if they are true- some employees health has been affected by these health and safety breeches). I cannot verify with certainty if any of this is true or factual, as it seems the whistle-blower got cold feet and didn’t follow up after a few emails- (for one reason or other maybe they got scared, which is understandable considering GSK’s reputation). However, I happened to stumble upon this strange (locked) blog which is called gsksligo.blogspot.uk, and a number of posts on Google plus (screen-shots below) which seem to be from a Whistle-blower involved in somehow attempting to alert the public to the alleged various issues (contamination etc) at the GSK Stiefel Site in Sligo, Ireland.

As I said already- I have no idea if this story on the aforementioned blog is true or not, so I am not responsible for the accuracy of these allegations, I am merely relaying information which was e-mailed to me and posting from information I found online, but something certainly seems a little strange and if these allegations are true it seems that people’s health has certainly been put at risk. The screenshots below (and the blog) is stuff I stumbled upon while merely Googling, therefore, they are not my responsibility (nor am I endorsing their content)- anyone can find them with a simple Google search. However from the information contained in the e-mails I originally received, I have no reason to doubt their sincerity or the authenticity of the original whistle-blower (who will of course remain anonymous). I would like to post more, but I will await word from the whistle-blower before I reveal the list of products produced at this site which are allegedly contaminated with asbestos (that’s if the source makes contact again- they might not). In the meantime- If anyone has any further information on this, please contact me on truthman30@gmail.com, furthermore if there is interest from media/journalists etc about this story- (perhaps they know more about this story?, maybe there is a legal case? or maybe I can lead them to a contact in order to explore further)- please mail me on the same e-mail.

Thanks..

It is worth noting that GSK have had issues of contamination in other plants (that we are aware of) such as in Cork, and Puerto Rico. Their safety record -or lack of it – (like a a lot of things GSK related- such as their ethics and morals) kind of speaks for itself.